View clinical trials related to Ulcer.
Filter by:The etiopathogenesis of ulcerative colitis (UC) is not fully understood. One of the theories of UC pathogenesis represents a pathological response of mucosal immunity to intestinal microbiota. Potential therapeutic procedure how to affect this fact is the faecal microbiota transplantation (FMT). Review of the literature on FMT suggests great potential as the treatment for UC, but two prospective controlled study that has been published yet are inconsistent. The first objective of the project is to compare the administration of FMT enema with mesalazine enema for inducing remission in patients with active left-sided UC in the form of a prospective, randomized, controlled study. The second objective is to observe changes in the intestinal microbiota during and after FMT focusing on bacterial DNA sequencing to identify the bacterial species which are responsible for the effect of the FMT.
This study is designed to evaluate the safety, tolerability, and pharmacokinetics (PK) of single-dose TD-3504 and single dose 15N2-tofacitinib in healthy subjects and subjects with UC. The relative bioavailability of tofacitinib released from TD-3504 compared to co-administered oral heavy-labeled tofacitinib (15N2-tofacitinib) will also be evaluated.
Azathioprine is considered first line immunomodulatory therapy for patients with ulcerative colitis. Up to 50% are treatment failures or experience adverse events leading to treatment withdrawal. Recent evidence suggests that the combination of allopurinol and low dose azathioprine increases the proportion of treatment responders and reduce the risk of adverse events. Objectives: To evaluate the beneficial and harmful effects of low dose azathioprine and allopurinol versus standard azathioprine monotherapy in patients with ulcerative colitis.
The primary objective of this trial is to understand the mechanism of action of BI655130 in patients with UC Secondary objectives are to explore clinical effect, safety and tolerability (including immunogenicity) of BI 655130 treatment
Enteral nutrition can provides prophylaxis against stress ulcer bleeding in critically ill patients and there may be no need to use acid suppressing drugs for stress ulcer bleeding prophylaxis in these patients. Half of the patients on enteral nutrition will not receive any acid suppressing drugs while other half receives it. They will be followed for gastrointestinal bleeding.
This Phase IIa study is an 8-week, double-blind, placebo-controlled, randomized study aiming at evaluating the safety and the efficacy of ABX464 given once a day (o.d) at 50 mg in subjects with moderate to severe Active Ulcerative Colitis who have failed or are intolerant to immunomodulators, Anti-TNFα, vedolizumab and/or corticosteroids followed by a one-month follow-up period.
Inflammatory Bowel Disease (IBD) is a chronic inflammatory disorder of the gastrointestinal tract that comprises two subtypes, Crohn's disease (CD) and Ulcerative Colitis (UC). Because the risk of IBD is greatest during the third decade of life, its impact for women is during the reproductive years. Women with inflammatory bowel disease are at a 2-fold higher risk of adverse outcomes during pregnancy as compared to the general population. Pregnancy is an especially vulnerable time for women with IBD, and out of misguided concerns that medications may confer unnecessary harms to their fetus, many women often stop taking life savings medications; without realizing that this sub-optimal adherence could actually lead to life threatening complications for them and their fetus. Counseling pregnant women with IBD is therefore an important step in improving medication adherence. The investigators hypothesize that counseling sessions with an IBD nurse that incorporates motivational interviewing and telemedicine-based follow-up sessions tailored to individual needs will improve medication adherence and pregnancy outcomes. The following specific aims are to be addressed by this multi-center randomized clinical trial comparing individual nurse-based counseling to standard of care: Specific Aim #1: To assess whether patient-centered counseling incorporating motivational interviewing and telemedicine-based follow-up by an IBD nurse leads to improved medication adherence during pregnancy and pregnancy outcomes Specific Aim #2: To validate the use of self-reported medication adherence during pregnancy in the IBD population
The purpose of this study is to establish the incidence of sub-optimal response to anti-TNF therapy in UC and CD participants.
Leg ulcers are a significant cause of impaired functional ability and quality of life for approximately 1-2 percent of the population in western countries. Although pain seems to be one of the most devastating aspects of living with a chronic ulcer, research is limited and there is a lack of knowledge about wound-related pain characteristics. Little is known about prevalence, pain intensity, qualities, location, temporal fluctuations, to witch degree pain impact on physical- and psychosocial functioning, as well as relieving and exacerbating factors. The overall purpose of this study is to investigate the prevalence and characteristics of wound related pain in patients with chronic leg ulcers. More specific research questions are: 1) What is the prevalence and characteristics of wound related pain in patients suffering from various types of persistent ulcers, 2) How do patients with different ulcer diagnoses report the quality of the wound related pain, 3) Is there any differences in wound pain characteristics among patients with different etiology leg ulcers, 4) How is the pain temporal pattern in patients with chronic leg- and foot ulcers, 5) What is the reported quality of life in patients with different ulcer diagnosis, and 6) Is there any association among pain characteristics, sleep and quality of life in patients with chronic leg/foot ulcers? The study has a non-experimental, explorative and descriptive approach. A cross-sectional questionnaire design will be used to explore patient's experience of wound-related pain. The patients will be recruited at the outpatient clinic appointment and home-care nursing in Norway. Participants will fill out self-report questionnaires. The battery of questionnaires will obtain information about demographic data, pain characteristics, quality of life and sleep. Pain characteristics, quality of life and sleep will be assessed by using different questionnaires that has demonstrated high validity and reliability. In addition, the temporal pattern of pain will be assessed by asking the participants to fill out a form stating subjective level of pain (NRS) every hour during a typical day, and to mark times that they rest and sleep. Relevant information about the diagnosis/classification of ulcer, comorbidities, the ulcer management and pain management will be collected in a clinical examination.
Conventional management of diabetic ulcers is associated with slow healing, high costs and repeated trips to clinic. Stem cells contained in fat grafts can differentiate into pro-healing cells and release growth factors with evidence suggesting a benefit in wound healing. Platelet-rich-plasma (PRP), an autologous blood-product, demonstrates pro-healing properties through releasing pro-healing factors and regulating angiogenesis. When used combination there is evidence of additional wound healing benefits. The aim is to investigate the feasibility of conducting a randomised controlled trial with fat grafting and fat/PRP co-grafting as interventions for diabetic ulcers. We aim to develop pilot data which can power a multi-centre study. The aim of the trial would be to determine the feasibility of the trial by assessing recruitment, randomisation and retention of participants. We would also evaluate the rate of wound healing in diabetic ulcers when treated with conventional dressings, fat grafting alone and fat+PRP combination. The secondary aims will be to understand the mechanism of the healing process, the health related quality of life and patient satisfaction and the cost implications. The study is a single-blinded randomised controlled trial of approximately 30 patients with three parallel treatment arms. Each patient will be followed up for 12 weeks and the rate and degree of wound healing will be assessed. Wound biopsies will be taken at Day 0, week 1 and week 4 and will undergo subsequent histological analysis to evaluate the mechanism of healing. The study is expected to last two years from recruitment of the first patient and will be conducted at Royal Free Hospital and UCL Division of Surgery and Interventional Science. The combination of fat+PRP may provide diabetic patients the option of a single treatment with improved healing, shorter followup and a reduced cost burden. Validation of the mechanism of healing through histological analysis will confirm clinical findings and help guide future research.